Senior Manager, QC Chemistry
Denali Therapeutics
August 13, 2026
On-site
Salt Lake City, UT
Operations
Key Accountabilities / Core Job Responsibilities
- Lead and develop the QC Chemistry team (up to 5 chemists); set priorities, build schedules, run tier huddles, and ensure coverage/cross-training.
- Hands-on lab leadership (~40–60%): chromatography testing, troubleshooting, record approvals, and bench mentoring.
- Own analytical method lifecycle (readiness; validation/verification/transfer); author/review protocols, reports, and change control.
- QC SME for HPLC/UPLC and core analytical techniques (e.g., UV/Vis); support biologics assays (e.g., CE-SDS, icIEF, potency) as needed.
- Ensure GMP/ALCOA+ data integrity and GDP; review/approve ELN/LIMS entries; maintain audit readiness.
- Lead OOT/OOS/deviation investigations, root cause analysis, and CAPAs; verify effectiveness and drive timely closure.
- Lead QC for method transfers; coordinate with AD/CMC/Manufacturing; define readiness and execute in QC.
- Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training, release-to-use) with ENG/vendors.
- Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates; oversee routine QC testing, stability, and sample management.
Qualifications / Skills
- BS in Chemistry, Biochemistry, or related field; 8+ years of GMP QC experience (pharma/biotech), including 3+ years people management.
- Strong hands-on chromatography experience (HPLC/UPLC required).
- Experience leading/mentoring small teams; method validation, transfer, and troubleshooting.
- Strong GMP and QC documentation/data integrity knowledge (ALCOA+).
- OOS/OOT investigations, root cause analysis, and CAPAs.
- Familiarity with CDS/ELN/LIMS (e.g., Empower, OpenLab).
- Biologics analytical experience (CE-SDS, icIEF, potency) is a plus.
- Ability to work onsite in Salt Lake City, UT with occasional off-shift support.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP (and other benefits).
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers
- Lead and develop the QC Chemistry team (up to 5 chemists); set priorities, build schedules, run tier huddles, and ensure coverage/cross-training.
- Hands-on lab leadership (~40–60%): chromatography testing, troubleshooting, record approvals, and bench mentoring.
- Own analytical method lifecycle (readiness; validation/verification/transfer); author/review protocols, reports, and change control.
- QC SME for HPLC/UPLC and core analytical techniques (e.g., UV/Vis); support biologics assays (e.g., CE-SDS, icIEF, potency) as needed.
- Ensure GMP/ALCOA+ data integrity and GDP; review/approve ELN/LIMS entries; maintain audit readiness.
- Lead OOT/OOS/deviation investigations, root cause analysis, and CAPAs; verify effectiveness and drive timely closure.
- Lead QC for method transfers; coordinate with AD/CMC/Manufacturing; define readiness and execute in QC.
- Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training, release-to-use) with ENG/vendors.
- Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates; oversee routine QC testing, stability, and sample management.
Qualifications / Skills
- BS in Chemistry, Biochemistry, or related field; 8+ years of GMP QC experience (pharma/biotech), including 3+ years people management.
- Strong hands-on chromatography experience (HPLC/UPLC required).
- Experience leading/mentoring small teams; method validation, transfer, and troubleshooting.
- Strong GMP and QC documentation/data integrity knowledge (ALCOA+).
- OOS/OOT investigations, root cause analysis, and CAPAs.
- Familiarity with CDS/ELN/LIMS (e.g., Empower, OpenLab).
- Biologics analytical experience (CE-SDS, icIEF, potency) is a plus.
- Ability to work onsite in Salt Lake City, UT with occasional off-shift support.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP (and other benefits).
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers